In a rare public split among federal health officials, the Health and Human Services Department overruled a decision by the Food and Drug Administration to make the drug available to anyone of any age without a restriction. In a statement, FDA Administrator Margaret A. Hamburg said she had decided the medication could be used safely by girls and women of all ages.But she added that Health and Human Services Secretary Kathleen Sebelius had rejected the move. "I agree ... there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential," Hamburg said. "However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency's decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential," she said.In a separate statement and letter to Hamburg, Sebelius said she overruled the FDA because she had concluded that data submitted by the company that makes the drug did not "conclusively establish" that it could be used safely by girls of all ages. "About 10 percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said. "If the application were approved, the product would be available, without prescription, for all girls of reproductive age."
The lack of any evident desire to present a united front is, I suspect, important here. I'd be very interested in what influences were brought to bear on Seblius or Obama. This is, evidently, the first time in history the FDA has been overruled by the head of HHS.
I'll have more as I get more info. This sort of thing is always sore around these parts. Keep your head. Be a good citizen. If you're overly heated take a break and do something else. You don't have to talk.
EDIT: Changed headline to better reflect what actually happened.
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